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Engineering Line Lead - Supervisor (Pharmaceutical CDMO)

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AI Summary

Lead and supervise engineers for a pharmaceutical CDMO's filling line, focusing on technical and project engineering aspects. Ensure compliance with GEPs and cGMPs, manage capital projects, and drive technical improvements. Requires a BS in Engineering, 5+ years of experience including 3+ in BioPharma and 2+ in Project Engineering/Management.

Key Highlights
Lead and supervise up to 3 Engineers on a specific filling line.
Responsible for technical and project engineering aspects of a sterile liquid compounding & vial filling line.
Ensure compliance with GEPs, cGMPs, and regulatory guidelines.
Key Responsibilities
Provide leadership, manufacturing support, and coordination for CMO line-specific projects.
Ensure contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company initiatives and guidelines.
Ensure line-specific compliance of CMO equipment and team with state, local, and federal regulations.
Ensure operations and projects are carried out under adherence to GEPs and cGMPs.
Provide technical oversight and leadership to the engineering team.
Drive technical improvements and responses to equipment and facility observations.
Manage assigned capital project schedules and budgets.
Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
Coordinate and supervise engineering resources for adequate staffing.
Ensure designated area, equipment, and engineering infrastructures are compliant to regulatory agencies.
Execute high-level projects from conception consistent with upper management objectives.
Manage and execute facility and equipment updates to meet company growth and economic objectives.
Support client audits and technical visits.
Effectively communicate project status, constraints, and potential issues to upper management.
Technical Skills Required
Project Engineering/Management Pharmaceutical Industry cGMP
Benefits & Perks
Salary range $120K - $165K+
Annual Bonus (10 %)
Full Benefits (Medical, Vision, Dental)
15 days' vacation/Sick time
10 Holidays
401k (match up to 4%)
Relocation Package
Nice to Have
BS in Mechanical, Chemical, Electrical, Manufacturing engineering
Advanced degree or PE or PMP certification
Experience with PM Software - MS Project
Design software - AutoCAD
ERP - SAP
Pharma sterile aseptic manufacturing, filling, Lyophilization
Interfacing with OEM equipment vendors
Construction/consulting partners

Job Description


Job DescriptionJob Description

Our client - a global and growing BioPharma CDMO company needs an Engineering Supervisor - Line Lead with Pharmaceutical Industry experience at their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Package.

Job Posting # 2703A

Job Title: Engineering Line Lead - Supervisor

Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES - The client offers a generous package for relo assistance.

Compensation: Salary range $120K - $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days' vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will be responsible for the technical aspects of 1 of the 4 lines

This role will report to the Engineering Director.

Note 1: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Note 2: The primary focus will be the technical and project engineering aspects of 1 complete filling line. This person will lead and supervise up to 3 Engineers.

Note 3: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

  • Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
  • Drive technical improvements and internal/external responses to equipment and facility observations.
  • Management of the assigned capital project schedules and budgets.
  • Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
  • Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
  • Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
  • Execute high level projects from conception, consistent with upper management objectives for business growth.
  • Manage and execute facility and equipment updates to meet company growth and economic objectives.
  • Support client audits and technical visits.
  • Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have

  • Bachelors of Science in Engineering or related technical degree.
  • 5+ years of Engineering Experience
  • 3+ years of Engineering experience in the BioPharma industry
  • 2+ years of Project Engineering/Management experience
  • Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
  • Facility or Manufacturing Engineering Experience
  • MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice To Have

  • BS in Mechanical, Chemical, Electrical, Manufacturing engineering
  • Advanced degree or PE or PMP certification
  • Experience with PM Software - MS Project, Design software - AutoCAD & ERP - SAP
  • Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
  • Interfacing with OEM equipment vendors, Construction/consulting partners

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